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Bioavailability of Phenolic Compounds in Bread

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ClinicalTrials.gov Identifier: NCT02353234
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
Daniele Del Rio, University of Parma

Brief Summary:
The consumption of wholemeal cereals has been associated with the reduction of several chronic diseases. The mechanisms behind these protective effects may be linked, besides dietary fiber and micronutrients, to an increased intake of phenolic compounds, mainly, hydroxycinnamates contained in the bran. Among bran fractions, aleurone usually contains the highest concentration of ferulic acid, principally contained as monomeric form and diferulic acid esters linked to arabinoxylans, representing the most relevant subclasses. The aim of the study was to evaluate the absorption of hydroxycinnamates by measuring the urinary excretion of phenolic metabolites in humans fed with two different kind of a commercial bread, as wholegrain bread and a white bread enriched with aleurone fraction. Moreover, the pharmacokinetics of the main phenolic compounds was also evaluated by measuring the circulating metabolites in plasma samples.

Condition or disease Intervention/treatment Phase
Dietary Modification Other: Bread Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Bioavailability of Phenolic Compounds in Wholegrain Bread Compared With White Bread Enriched With Aleurone Fraction
Study Start Date : December 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : July 2015

Arm Intervention/treatment
Active Comparator: WHOLEGRAIN BREAD
Subjects feed with wholegrain bread, for which ferulic acid content has been quantified.
Other: Bread
In each arm subjects consume bread

Active Comparator: WHITE BREAD WITH ALEURONE - 4
Subjects feed with white bread with aleurone fraction in the same portion as wholegrain bread.
Other: Bread
In each arm subjects consume bread

Active Comparator: WHITE BREAD WITH ALEURONE - 8
Subjects feed with white bread with aleurone fraction, which contains the same quantity of ferulic acid as wholegrain bread.
Other: Bread
In each arm subjects consume bread




Primary Outcome Measures :
  1. Phenolic compound bioavailability in wholegrain bread compared with bread enriched with aleurone fraction (urine samples will be filtered and diluted and phenolic compound metabolites will be identified) [ Time Frame: 0h; 0-3h; 3-6h; 6-10h; 10-14h; 14-24h; 24-28h; 28-34h; 34-48h. ]

    Volunteers will collect urine before consuming bread (T0) and for 48 hours after the consumption of the meal test, in each study arms. Urine samples will be collected and stored at -80°C until uHPLC/MS analysis. Prior analysis, urine samples will be filtered and diluted and phenolic compound metabolites will be identified.

    Expected Metabolites:

    Coumaric acid, Hydroxyphenylpropionic acid, Dihydroxyphenylacetic acid, Hippuric acid, Enterolactone, Enterodiol, Coumaric acid sulphate, Phenylpropionic acid sulphate, Vanillic acid sulphate, Hydroxyphenylpropionic acid sulphate, Ferulic acid sulphate, Dihydroferulic acid sulphate, Hydroxyphenylpropionic acid glucuronide, Ferulic acid glucuronide, Enterolactone sulphate, Enterodiol sulphate, Enterolactone glucuronide, Enterodiol glucuronide.



Secondary Outcome Measures :
  1. Phenolic compound pharmacokinetics in wholegrain bread compared with bread enriched with aleurone fraction (metabolites identified in Plasma samples that will be collected prior (T0) and after bread consumption in each study arms.) [ Time Frame: 0h; 0.5h; 1h; 2h; 4h; 7h; 24h. ]

    Plasma samples will be collected prior (T0) and after bread consumption in each study arms.

    Expected Metabolites:

    Coumaric acid, Hydroxyphenylpropionic acid, Dihydroxyphenylacetic acid, Hippuric acid, Enterolactone, Enterodiol, Coumaric acid sulphate, Phenylpropionic acid sulphate, Vanillic acid sulphate, Hydroxyphenylpropionic acid sulphate, Ferulic acid sulphate, Dihydroferulic acid sulphate, Hydroxyphenylpropionic acid glucuronide, Ferulic acid glucuronide, Enterolactone sulphate, Enterodiol sulphate, Enterolactone glucuronide, Enterodiol glucuronide.




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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI 18-25 kg/m2

Exclusion Criteria:

  • Pregnancy and breastfeeding
  • diagnosis of celiac disease
  • diagnosed methabolic diseases (diabetes and disorders of glycaemic control, hypertension, dyslipidemia)
  • sustained use of nutritional supplements of vitamins, in particular E and C, at the recruitment step
  • chronic pharmacological therapy
  • antibiotic therapy during the last 40 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353234


Locations
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Italy
University of Parma - Department of Food Science
Parma, Italy, 43125
Sponsors and Collaborators
University of Parma
Investigators
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Principal Investigator: Daniele Del Rio, Professor University of Parma
Publications:

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Responsible Party: Daniele Del Rio, Associate Professor, University of Parma
ClinicalTrials.gov Identifier: NCT02353234    
Other Study ID Numbers: DDR-001
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: December 2015
Keywords provided by Daniele Del Rio, University of Parma:
Phenolics
Aleurone
Bioavailability
Pharmacokinetics